Recall Z-0878-2026— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0878-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-24

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-10-24. It names one FDA 510(k) clearance: K123520. Product: MAMMOMAT Inspiration;. Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-10-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123520 — MAMMOMAT INSPIRATION PRIMESiemens Medical Solutions USA, Inc.·cleared 2013-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MAMMOMAT Inspiration;

Reason for recall

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Data sourced from openFDA. This site is unofficial and independent of the FDA.